Chemotherapy-induced peripheral neuropathy
Conditions
Interventions
Traditional Chinese medicine group:Chinese medicine LC07
Comparison group:Placebo
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed cancer patients with level 1 or above CIPN after receiving chemotherapy as part of routine standard care; 2. NRS=4 (0-10); 3. Aged between 18 to 80 years old; 4. ECOG performance status 0-2; 5. Life expectancy greater than or equal to 3 months; 6. No serious heart, liver, kidney and other important viscera dysfunction; 7. Ability to cooperate with CIPN grade evaluation, understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Concurrent with level 1 or above peripheral neuropathy (such as diabetic neuropathy or chemotherapy induced peripheral neuropathy); 2. Concurrent with other skin lesions in the hands and feet(such as hand-foot syndrome caused by chemotherapy); 3. Plans to take other drugs that may impact the effect of drugs for CIPN (such as Dutoxetine); 4. History of severe or uncontrolled organic disease or infection; 5. Pregnant (positive pregnancy test) or nursing women; 6. Participating in other clinical trial currently or within 4 weeks; 7. Significant neurological, psychiatric history, including dementia, which may affect comprehension and informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NCI grade;NRS;Instrumental Activity of Daily living;FACT/GOG-Ntx;EORTC QLQ-CIPN20;Nerve growth factor, NGF;Nerve conduction studies, NCS; | — |
Countries
China
Contacts
Public ContactYanni Lou
China-Japan Friendship Hospital
Outcome results
None listed